Last reviewed 2026-04-20 · How we verify

Zenadrex (DELMADINONE ACETATE)

Phase 2 active Small molecule

Zenadrex (generic name: DELMADINONE ACETATE) is a drug. It is currently in Phase 2 development.

Delmadinone Acetate is a synthetic steroid that works by binding to specific receptors in the body to produce its therapeutic effects.

Zenadrex, also known as Delmadinone Acetate, is a small molecule medication with unknown target and drug class. Its commercial status is unclear, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its pharmacokinetics, safety, and efficacy. Further research is needed to determine its potential therapeutic applications and risks. Due to the lack of available data, it is challenging to provide a comprehensive summary of Zenadrex.

Likelihood of approval

16.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	DELMADINONE ACETATE
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Delmadinone Acetate is a key that fits into those locks. When it binds to the locks, it sends a signal to the cell to do something specific, like reducing inflammation or suppressing the immune system. This is a simplified explanation of how Delmadinone Acetate works at a molecular level.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Zenadrex CI brief — competitive landscape report
Zenadrex updates RSS · CI watch RSS

Frequently asked questions about Zenadrex

What is Zenadrex?

Zenadrex (DELMADINONE ACETATE) is a Small molecule drug.

How does Zenadrex work?

Delmadinone Acetate is a synthetic steroid that works by binding to specific receptors in the body to produce its therapeutic effects.

What is the generic name of Zenadrex?

DELMADINONE ACETATE is the generic (nonproprietary) name of Zenadrex.

What development phase is Zenadrex in?

Zenadrex is in Phase 2.

Therapeutic area: All drugs in Immunology

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing